A phase I/IIa clinical trial of third-generation autologous chondrocyte implantation (IK-01) for focal cartilage injury of the knee.

ABSTRACT:

Background/objective

The purpose of this study was to report the outcomes of a clinical trial conducted in Japan to assess the safety and effectiveness of third-generation autologous chondrocyte implantation (ACI) using IK-01 (CaReS™), which does not require flap coverage, in the treatment of patients with focal cartilage injury of the knee.

Methods

This was an open label, exploratory clinical trial. Patients were enrolled between June 2012 and September 2016. The primary endpoint of the study was the International Knee Documentation Committee (IKDC) score at 52 weeks after implantation. The IKDC, Lysholm, and visual analog scale (VAS) scores were evaluated at the time of screening and at 4, 12, 24, 36, and 52 weeks after implantation. Improvements from the baseline scores w

SUBMITTER: Matsushita T 

PROVIDER: S-EPMC8967970 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature